MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH LOCKSCR SYNAPSE TAN; ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION

Catalog Number 04.614.508

Device Problems Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problems Neurological Deficit/Dysfunction (1982); Pain (1994); No Code Available (3191); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown screw/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.Without a lot number the device history records review could not be completed.Product was not returned.Based on the information available, it has been determined that no corrective and/or preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.(b)(4).Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Event Description

Device report from (b)(6) reports an event as follows: it was reported that on (b)(6) 2019 the patient underwent a cervical vertebrae fusion from the 3rd to 5th cervical vertebrae due to a fracture of the 5th vertebrae.On (b)(6) 2020 the patient complained about head aches, pain in the shoulder while eating, and pain on the right side.The patient was also unable to feel cold and warm.On (b)(6) 2020 it was noted that the right rod had moved completely into the brain.The left rod had also moved towards brain but still remained in the c3 and c4 screw head.A revision operation was performed on (b)(6) 2020.The skull was opened to remove the right rod from the brain.The left rod was also removed.To remove the left rod a screw driver had to be used.A normal amount of force was used to loosen the screw and nut which weren't loose.The skull was closed with a small plate and cement.A new rod was placed into the existing screws which were tightened with nuts.The revision surgery was completed successfully.The head and shoulder pain has become less.This report is for one (1) unknown screw.This is report 6 of 10 for (b)(4).This report is linked to (b)(4).

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Visual inspection: the lockscr synapse tan (p/n: 04.614.508, lot number: h858391) was received at us cq.Visual inspection of the complaint device showed minor scratches eventually due to the implantation and explantation of the device.No other irregularity or defects were observed on the returned device.The x-ray images provided did not provide a clear pictures of the locking screws in question.Functional test: a functional assessment was not performed with the complaint device since all applicable mating component(s) were not returned.Can the complaint be replicated with the returned device? complaint could not be replicate.Document/specification review: (current and manufactured to) was reviewed.No design issues or discrepancies were identified.Complaint confirmed? yes.Investigation conclusion: the overall complaint is confirmed as the x-ray image provided showed a synapse rod displaced from its original position to migrate toward the brain.However the as received condition of the lockscr synapse tan (p/n: 04.614.508, lot number: h858391) showed no defect that could contribute to the reported allegation.Only minor and light scratches were observed on the screw but they were expected as the device was implanted and then explanted.No definitive root cause could be determined based on the information available for the reported complaint condition but it is likely device (s) failure occurred.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device history lot manufacturing location: supplier - general machine inc./ inspected, packaged and released by: monument.Release to warehouse date: 14-may-2019, part number: 04.614.508, ti locking screw, lot number: h858391 (non-sterile) , lot quantity: 255.Production order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, 04if614508 rev m met all inspection acceptance criteria.Certificate of compliance received from general machine, inc.Dated 12-apr-2019 was reviewed and determined to be conforming.Packaging label log (pll) was reviewed and determined to be conforming.Packaging bom was reviewed and determined to be conforming with no deviations to normal packaging identified.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the inspection or release of this product that would contribute to this complaint condition.Component part(s) reviewed: part number: bk100018, blank 9.5mm ti w/t15 stardrive, 16mm long, lot number: h800888, lot quantity: 1,053.Work order traveler met all inspection acceptance criteria.Inspection sheet, incoming final inspection, t15it032 rev e met all inspection acceptance criteria.Certificate of compliance supplied by universal punch corp.Dated 28-feb-2019 was reviewed and determined to be conforming.Device history review, 22-oct-2020: dhr reviewed.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H6: health effect - clinical code of e2402 used to capture nervous system (e01).H3, h4, h6: part 04.614.508, lot h858391: manufacturing location: supplier - (b)(4)/ inspected, packaged and released by: monument.Release to warehouse date: may 14, 2019.This lot met all dimensional, visual and packaging criteria at the time of release with no issues documented during the manufacture that would contribute to this complaint condition.H3, h6: a product investigation was completed: visual inspection of the complaint device showed minor scratches eventually due to the implantation and explantation of the device.No other irregularity or defects were observed on the returned device.The x-ray images provided did not provide a clear picture of the locking screws in question.A functional test was not performed as not all mating devices were returned.Dimensional inspection showed the relevant dimensions were within the specification.The current and manufactured revisions of the drawings were reviewed; no design issues or discrepancies were identified.The overall complaint is confirmed as the x-ray image provided showed a synapse rod displaced from its original position to migrate toward the brain.However, the as received condition of the locking screw showed no defect that could contribute to the reported allegation.Only minor and light scratches were observed on the screw, but they were expected as the device was implanted and then explanted.No definitive root cause could be determined based on the information available for the reported complaint condition but it is likely device (s) failure occurred.No new, unique or different patient harms were identified as a result of this evaluation.There was no indication that a design or manufacturing issue contributed to the complaint.No design issues were observed during the document/specification review.Based on the investigation findings, it has been determined that no corrective and/or preventive action is proposed.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post market safety surveillance activities.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Investigation summary: the complaint condition, that both synapse rods migrated, could be confirmed according to the received x-rays.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: LOCKSCR SYNAPSE TAN
• Type of Device: ORTHOSIS, SPONDYLOSTHESIS SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 10559836
• MDR Text Key: 207712283
• Report Number: 8030965-2020-07236
• Device Sequence Number: 1
• Product Code: MNH
• Combination Product (y/n): N
• PMA/PMN Number: K142838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 04.614.508
• Device Lot Number: H858391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Date Manufacturer Received: 11/25/2020
• Patient Sequence Number: 1
• Treatment: CONNEC-ROD Ø4/6 L500 Ø4/240 Ø6/255 TAN; CONNECTING ROD; HANDLE W/TORQ LIMIT 2NM W/QUICK-COUPL; HANDLE W/TORQ LIMIT 2NM W/QUICK-COUPL; LOCKSCR SYNAPSE TAN; LOCKSCR SYNAPSE TAN; LOCKSCR SYNAPSE TAN; LOCKSCR SYNAPSE TAN; ROD Ø3.5 L240 TI GOLD; ROD Ø3.5 L240 TI GOLD; UNK - MONO/POLYAXIAL SCREWS: SYNAPSE; UNK - MONO/POLYAXIAL SCREWS: SYNAPSE
• Patient Outcome(s): Required Intervention