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OBERDORF SYNTHES PRODUKTIONS GMBH TI LOCKING SCREW - STERILE; ORTHOSIS, CERVICAL PEDICLE SCREW SPINAL FIXATION
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| Catalog Number 04.614.508S |
| Device Problem
Unintended Movement (3026)
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| Patient Problem
Failure of Implant (1924)
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| Event Date 12/12/2019 |
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Event Type
Injury
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Manufacturer Narrative
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Without a lot number the device history records review could not be completed.Product was not 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.
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Event Description
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Device report from synthes reports an event in (b)(6) as follows: it was reported that on (b)(6) 2019, the setscrew on the c5 pedicle screw came off.An anterior-posterior cervical spinal fusion (c2-c5) treating cerebral palsy was performed on (b)(6) 2019.A pedicle screw (4mm in diameter) was deployed to c5.The patient will undergo a revision procedure for either re-tightening of the setscrew in question or replacing implants.No further information is available.Concomitant device reported: unk - ti curved rod (part#: unknown; lot#: unknown; quantity: 1); unk - ti cancellous polyaxial screws (part#: unknown; lot#: unknown; quantity: 1).This report is for one (1) ti locking screw.This is report 1 of 1 for (b)(4).
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Manufacturer Narrative
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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.It was reported that after an anterior-posterior cervical spinal fusion the locking screw synapse (04.614.508s) came off.The returned locking screw was forwarded to the responsible product development center for evaluation.Summary pd evaluation: the locking screw shows minor traces of wear, therefore it seems obvious that the locking screw was used within surgery.Furthermore, there are no indications or traces indicating some non-conformity or product failure.The review of the device history record revealed that this locking screw was manufactured according to the specifications.The parts conformed to dimensional specifications at the time of manufacturing and passed inspection requirements with no non-conformities reported.One of our own pedicle screws (04.615.208 lot:6203752) was used with the returned locking screw 04.614.508s lot: 5l75668 in functional test to determine if locking screw would work as required, intended and described in surgical technique guide (stg).No malfunction or failure observed.Nevertheless, it has no significance on the reported complaint, since involved pedicle screw remained in patients¿ body and therefore, a full compatibility analysis was not possible.Final conclusion: with the received parts no complaint root cause can be identified or defined.Based on the information available, 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.The following parts were returned as concomitant devices without an alleged complaint condition ¿ two screwdriver shafts (03.614.019 lot h527374) and one handle w/torque limiter, 2.0 nm (03.614.035 lot h528431-14).Upon inspection no evidence was found that would cause or contribute to the reported complaint condition.Device history part: 04.614.508s, lot: 5l75668, manufacturing site: selzach, supplier: (b)(4), release to warehouse date: 20 aug 2019, expiry date: 01 aug 2029.Since there is no allegation against packing or sterility dhr review is done for non-sterile part: part: 04.614.508, lot: h884020.Manufacturing location: supplier ¿ general machine inc./ inspected, packaged and released by: monument.Release to warehouse date: 15-jul-2019, part number: 04.614.508, ti locking screw, lot number: h884020 (non-sterile) , lot quantity: 247.Six pieces were scrapped in cell at op #20, incoming inspection, for destructive sampling purposes.Production order traveler met all inspection acceptance criteria apart from the six pieces noted.Inspection sheet, incoming final inspection, met all inspection acceptance criteria.Certificate of compliance supplied by general machine dated 24-may-2019 was reviewed and determined to be conforming.Packaging label log 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: component part dhrs were not reviewed as the reported complaint condition of pedicle screw came off¿ does not indicate breakage of the screw.Therefore, review of the raw materials would not be pertinent to the reported complaint condition.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.
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Event Description
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Updated event description: concomitant device reported: unk - ti curved rod (part# unknown; lot# unknown; quantity 1), unk - ti cancellous polyaxial screws (part# unknown; lot# unknown; quantity 1), unk - mono/polyaxial screws: synapse (part# unknown; lot# unknown; quantity 1), unk - rods: synapse (part# unknown; lot# unknown; quantity 1).
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Manufacturer Narrative
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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.
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Manufacturer Narrative
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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.H11: corrected data: g4: awareness date reported on follow up 2 report as december 12, 2019 but should have been february 04, 2020.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.
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