MAUDE Adverse Event Report: OBERDORF SYNTHES PRODUKTIONS GMBH; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Device Difficult to Maintain (3134)

Patient Problem No Code Available (3191)

Event Type  Injury  

Manufacturer Narrative

510k: this report is for an unknown unk - constructs: uss/unknown lot.Part and lot number are unknown; udi number is unknown.Complainant part is not expected to be returned for manufacturer review/investigation.(b)(4).Without a lot number, the device history records review could not be completed as no product was received.The investigation could not be completed; no conclusion could be drawn.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.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.[(b)(4)].

Event Description

Device report from synthes reports an event in germany as follows: this report is being filed after the review of the following journal article: niemeyer, t.Et al (2000), anterior thoracoscopic surgery followed by posterior instrumentation and fusion in spinal deformity, european spine journal, vol.9, pages 499-504 (germany).The purpose of this study was to evaluate the efficacy and safety of thoracoscopic anterior release or growth arrest in a series of consecutive patients with a scoliotic or kyphotic deformity, specifically with respect to the clinical and radiological outcome.Between 1995 to 1997, a total of 29 patients (12 male and 17 female) with a mean age of 16 (range 5-26) were included in the study.In 22 patients an anterior release was performed, and in 7 patients an additional anterior growth arrest was performed.Twentysix patients were instrumented posteriorly using the universal spine system (synthes, switzerland).The mean duration of follow-up was 2 years (range 1-4 years).The following complications were reported as follows: 4 patients had four recurrent pneumothoraces (3 of which required insertion of a chest drain).1 patient had surgical emphysema.1 patient had chest infection.2 patients underwent revision surgery.The first patient required extension of posterior fusion from l1 to l3 for progressive caudal deformity.The other patient had a reported back pain at 12 months.In this group (idiopathic scoliosis), 2 patients showed marked loss of correction.The first one (king type iii) was operated early on in the series, and did not receive a sufficient growth arrest.Within the instrumentation (t5¿l1), the curve progressed from 16° postoperatively to 48° at 24 months.At follow-up (48 months) there was no further progression, and the patient was simply kept under observation.The second patient (king type iii) showed caudal progression of the deformity 18 months postoperatively.This was due to the original fusion being too short.There was no loss of correction within the instrumentation (t4¿l1).The patient was revised, with the instrumentation extended to l3.This report is for a universal spine system (synthes, switzerland).This report is for one (1) unk - constructs: uss.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.Device code: omit 3134 and replace with 2993.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.

• Type of Device: ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
• Manufacturer (Section D): OBERDORF SYNTHES PRODUKTIONS GMBH; eimattstrasse 3; oberdorf 4436 ; SZ 4436
• MDR Report Key: 8520881
• MDR Text Key: 142191500
• Report Number: 8030965-2019-62856
• Device Sequence Number: 1
• Product Code: NKG
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup,Followup
• Report Date: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/17/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention