MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-19 for ADULT RADIOLUCENT HORSESHOE A2010 manufactured by Integra Lifesciences Corporation Oh/usa.
[65666322]
On (b)(6) 2016, the doctor was performing a removal of cervical (c-5, c-6) artificial disc, cervical (c-3, c-6) anterior cervical discectomy and fusion on a (b)(6) male patient. At approximately 1700 hours, at the conclusion of this procedure, and during the placement of the final screw, the a2010 radiolucent horseshoe underwent a failure and dropped away from the patient. It was deemed to be secondary to shearing of the radiolucent pin. The patient's head was immediately grabbed through the drapes and supported until the head of the bed could be affixed beneath the drapes. The mayfield was then removed from the field and replaced with an alternate device. The patient was still under anesthesia at this point. There was no patient injury. The incident led to a 30 minute delay in the surgery. The broken mayfield was then immediately reported to the integra rep with a photo and requested to be sent in for further evaluation.
Patient Sequence No: 1, Text Type: D, B5
[71010070]
Additional information received from fda on 13feb2017: as per sus voluntary event report number: mw5067502. At conclusion of this procedure, during the placement of the final screw, the mayfield radiolucent head holder underwent a failure and the head unfortunately dropped away from the patient secondary to shearing of the radiolucent pin. The patient's head was immediately grabbed through the drapes and supported until the head of the bed could be affixed beneath the drapes. Date of event: (b)(6) 2016. Integra has completed their internal investigation on 02/07/2017. The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history. Results: the device history record for the unit(s) listed in this complaint under lot code/work order: (b)(4). A total of (b)(4) were produced of this lot on 11/06/15. The devices manufactured during this period passed all required inspection points with no associated mrr? S, variances or rework. No service history is on file for this device. A two year lookback in trackwise for this reported failure and or related to "cracked or broke" for this product family shows that 5 complaints were received including this case. No new design or manufacturing trends have been identified. Conclusion: engineering and quality were able to verify the customer complaint. The root cause cannot be attributed at this time. There is a chance that the fracture was caused by fatigue cracking due to an axial tension load (tightening of the drawbar) and/or bending load which exceeded the strength of the material. This unit was manufactured in 2015 and this is the first time it was sent in for repairs.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004608878-2017-00018 |
| MDR Report Key | 6265175 |
| Date Received | 2017-01-19 |
| Date of Report | 2017-01-03 |
| Date of Event | 2016-12-30 |
| Date Mfgr Received | 2017-02-07 |
| Device Manufacturer Date | 2015-11-06 |
| Date Added to Maude | 2017-01-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | USER ROWENA BUNUAN |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Street | 4900 CHARLEMAR DRIVE |
| Manufacturer City | CINCINNATI OH 45227 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 45227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ADULT RADIOLUCENT HORSESHOE |
| Generic Name | RADIOLUCENT PRODUCT ACCESSORIES |
| Product Code | HBM |
| Date Received | 2017-01-19 |
| Returned To Mfg | 2017-01-10 |
| Catalog Number | A2010 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA LIFESCIENCES CORPORATION OH/USA |
| Manufacturer Address | 4900 CHARLEMAR DRIVE 4900 CHARLEMAR DRIVE CINCINNATI OH 45227 US 45227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-01-19 |