MAUDE Adverse Event Report: SYNTHES USA; ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

This report is for one (1) unknown spine matrix system.Device is expected to be returned for manufacturer review/investigation, but has not been received yet.(b)(4).Device evaluation/investigation could not be completed; no conclusion could be drawn as product was not returned to manufacturer.Device history records review could not be completed without lot number.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 synthes europe reports an event in (b)(6) as follows: it was reported that on (b)(6) 2016 a removal surgery for matrix system was performed due to a protrusion of the implanted screw.The fixing area was l1 to l3.After the surgery, it was found that here was a metallic fragment in the patient's body under ct-scan.On (b)(6) 2016 the removal surgery was performed to remove fragment.It was unknown which device generated fragments.No fragments remained in the patient's body.Patient¿s condition reported as stable.This report is for one (1) unknown spine matrix system.This is report 1 of 1 for (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.Additional narrative: describe event or problem.Brand name, common device name, mfr name, city, and state, model #/lot #: the fragment is from one of the following implants/instruments, but it unknown which: part 04.632.640s, lot unknown; brand name: 6.0mm ti matrix polyaxial screw 40mm thread length; common name: orthosis, spinal pedicle fixation, for ddd; product codes: nkb, mnh, mni, kwq, kwp; 510k: k100952; udi: (01)10705034745527(17)expiration unknown(10)lot unknown.Part 04.632.645s, lot unknown; brand name: 6.0 mm ti matrix polyaxial screw 45 mm thread length; common name: orthosis, spinal pedicle fixation, for ddd; product codes: nkb, mnh, mni, kwq, kwp; 510k: k100952; udi: (01)10705034745534(17)expiration unknown(10)lot unknown.Part 04.633.282s, lot unknown; brand name: 5.5 mm ti rod 200 mm; common name: orthosis, spinal pedicle fixation, for ddd; product codes: nkb, mnh, mni, kwq, kwp; 510k: k100952; udi: (01)10705034746463(17)expiration unknown(10)lot unknown.Part 04.633.333s, lot unknown; brand name: ti snap-on transconnector 33 mm-38 mm for 5.5 mm/6.0 mm rods; 510k: k100952; udi: (01)10705034746654(17)expiration unknown(10)lot unknown.Part 994-856, lot unknown; brand name: head opener lateral spread.This is not a synthes device so the common name, product code and 510k number and udi number are unknown.Complainant part is no longer expected to be returned for manufacturer review/investigation.(b)(6).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

The revision for the protrusion of the implanted screw is being captured under linked complaint (b)(4).It was reported at the end of that procedure, the devices were not checked so it is unknown if the retained fragment came from an implant or one of the instruments.

Manufacturer Narrative

A product development investigation was performed for the subject device (unknown spine instrument, part number unknown, lot number unknown).The subject device was returned with the complaint condition stating: we have received a foreign fragment like reported for investigation.Based on the complaint description, it was unsure that the fragment was the part of any implants or any devices.In addition, they did not check the devices after the surgery if one of them had a broken off part missing.Therefore, we are not able to determine where this fragment might have broken off.In addition, as no article and no lot number were reported a review of the device history record was not possible.With the available information and the returned fragment, we can state that this fragment in its present condition would not have left the manufacturing plant.Root cause for this complaint could not be found.No manufacturing related failure could be found.Only a fragment of the unknown device was returned.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.

• Type of Device: ORTHOSIS, SPINAL PEDICLE FIXATION, FOR DDD
• Manufacturer (Section D): SYNTHES USA; 1302 wrights lane east; west chester PA 19380
• Manufacturer Contact: michael cote ; 1302 wrights lane east; west chester, PA 19380 ; 6107195000
• MDR Report Key: 6181066
• MDR Text Key: 62600316
• Report Number: 2520274-2016-15692
• Device Sequence Number: 1
• Product Code: NKB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention